Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 23, 2024
Date Accepted: Apr 4, 2025
Integrated Psychosocial Care in Intensive Care (IPS-Pilot): Study Protocol of the Systematic, Multi-Method Development of a Complex Intervention (Phase A)
ABSTRACT
Background:
There is a high and co-dependent strain on health care professionals (HCPs), patients and their relatives in intensive care units (ICUs), leading to long-term mental, physical and occupational consequences. To this date, there is no systematic intervention to address this increasing problem.
Objective:
The aim of the IPS-Pilot project is the development (phase A) and pilot testing (phase B) of an integrated and complex psychosocial care intervention for HCPs, patients, and their relatives in ICUs. This study protocol focuses on phase A. A protocol for phase B will be published separately.
Methods:
A structured, multi-method approach was used to gather evidence on the needs, expected benefits and necessary conditions for implementation from the above target groups. These methods included: 1) a scoping umbrella review conducted by two researchers who independently screened and selected reviews and meta-analyses conducted in the field of needs and demands in the ICU setting according to the Levac framework, 2) web-based and face-to-face interviews and focus group discussions, coded by two researchers independently and analyzed with qualitative content analysis by Kuckartz, with the identified categories and codes then being quantified by 3) an online survey with former ICU patients, their relatives, HCPs working in ICUs and the general population. Synthesized results, complemented with the theories of Psychosocial Safety Climate (PSC) and Conservation of Resources (COR) as well as online and face-to-face stakeholder workshops, were used for intervention development which was based on the Intervention Mapping framework.
Results:
Through the four substudies, we aim to gain insight into the psychosocial needs of the above-mentioned target groups. We performed intermediate analyses to develop a model of the problem as well as a model of how these needs can be effectively addressed through a psychosocial intervention involving the integration of a clinically trained psychologist into the HCP team. Data collection and analysis for the intervention development was completed by June 2024 (Substudy 1: N=104 included articles, Substudy 2: N=22 interviews and N=18 participants in focus groups, Substudy 3: N=237 participants in the survey, Substudy 4: N=11, N=15 and N=20 participants in three consecutive workshops), with further analyses still being conducted that go beyond the intervention development. The results of the substudies as well as the final, needs-based intervention design will be published separately. These findings set the base for the feasibility study (phase B) from July 2024 to July 2025 in which the intervention will be implemented in randomly selected ICU wards and evaluated in terms of feasibility.
Conclusions:
Phase B will assess the feasibility of the IPS intervention. These findings will then be incorporated into our intervention design and provide the basis for a future randomized controlled trial of its efficacy. Clinical Trial: osf.io; [10.17605/OSF.IO/VFXJK], registered on 30/04/2023
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